Clinical trials in cell and gene therapy

A clinical trial is a research study that seeks to determine if a treatment is safe and effective. Advancing new cell and gene therapies from the laboratory into early-phase clinical trials has proven to be a complex task even for experienced investigators. Due to the wide variety of CGT products and their potential applications, a case-by-case assessment is warranted for the design of each clinical trial.

Objectives: Determine the pharmacokinetics of this regimen by the persistence of modified T cells in the blood of these patients, Evaluate the immunogenicity of murine sequences in chimeric anti-CEA Ig TCR, Assess immunologic parameters which correlate with the efficacy of this regimen in these patients, Evaluate, in a preliminary manner, the efficacy of this regimen in patients with CEA bearing tumors.

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